Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-24 @ 5:17 PM
Ignite Modification Date: 2025-12-25 @ 2:54 PM
NCT ID: NCT04797650
Description: All-cause mortality: All randomized participants included all participants who were randomized in the study. Adverse events: Safety Population included all participants who received study drug during the treatment period.
Frequency Threshold: 5
Time Frame: All-cause mortality: Randomization up to Week 28; Adverse events: From first dose of study drug up to last follow up visit (Week 28)
Study: NCT04797650
Study Brief: Study to Evaluate the Efficacy and Safety of CTP-543 in Adults With Moderate to Severe Alopecia Areata (THRIVE-AA2)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Participants received CTP-543 matched placebo tablets, orally, BID for up to 24 weeks. 0 None 0 130 60 130 View
CTP-543 8 mg BID Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks. 0 None 3 256 137 256 View
CTP-543 12 mg BID Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks. 0 None 2 129 67 129 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Radius fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.1 View
Migraine with aura SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.1 View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.1 View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.1 View
Pneumonia influenzal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.1 View
Acne SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.1 View
Blood creatine phosphokinase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.1 View
Asymptomatic COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.1 View